TST-C - Thomas Schmidt Consultants

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Interim Project Manager Engineering
Burgwedel Biotech 2016 – 2018

Project management for reconstruction and improvement projects in an Animal Health Pharmaceutical Factory of Merck Sharp & Dome (MSD) production site. Project planning and engineering, RFQ‘s and bid processing, contracting and construction site supervision as well as risk analysis, DQ, IQ, OQ and planning and supporting PQ for piping systems, vessels/tanks, exchange and refurbishment of autoclaves and extension and reconstruction of the WFI and clean steam system.

Senior Project Manager
Haupt Pharma Wolfratshausen 2017

For conceptioning and budgeting for the new optical inspection and the extention of the steril filling lines.

Scope of project was the evaluation of the demand, development of different realisation concepts and layouts in cooperation with production, engineering and management. Preparation of room books and quantity structure.  RFQs by reliable vendors, cost calculation for each lot. Compilation of the project budget and the master project schedule for all 5 project parts over 4 years with focus on resource planning intern and extern for realisation and qualification. Preparation of the project application and a decision memo for the management

Senior Vice President Sales, Marketing and Engineering
Kinetics Germany Eschau-Hobbach 2015

As Interim Manager responsible for the reorganisation and new structuring of the sales and marketing for high purity systems, plant engineering and construction in the Biotechnological, Pharmaceutical and Semiconductor production environment in Europe und Middle East as well as the structuring and re-staffing of the engineering department in the headquarter in Germany.

Senior Project Manager
Haupt Pharma Wolfratshausen 2014

Engineering, Construction and Qualifikation of a new clean room for sterile pharmaceutical production

Scope of project was the relocation of a filling line for ampules and several packing lines for solida. Evaluation of demand, local conditions and user requirements, writing of the project validation master plan (VMP), the DQ-URS documents, the project budget application, project schedule and change management  for the relocation of the filling and packing lines (Marchesini, Cremer/Kugler). Project planning and engineering, RFQ‘s and bid processing, contracting and construction site supervision as well as risk analysis, DQ, IQ, OQ and planning and supporting PQ for Room and filling machine. Supporting process validation of the Bosch isolator ampule filling line and validation of new CIP/SIP processes for the bulk mixing and transport tanks.

Project Management SOP’s and cGMP compliant processes
Lamers HTS Nijmegen 2013

Project management for the development and implementaton of Lamers own Standard Operating Procedures (SOP’s) for high purity piping installations in pharmacy, biotechnology and  food industrie according cGMP and FDA guidlines, in Nijmegen The Netherlands. This program addresses the documentation and control of activities performed by the mechanical contractor during the fabrication, installation, and acceptance testing of piping systems to be used in any facility determined by its owner to fall under the requirements of current Good Manufacturing Practice as interpreted and enforced by the European Union and the Food and Drug Administration of the United States.

Project Management, Plant Engineering and Construction
RheinBiotech Düsseldorf 2012/13

Project management for the new CDA/CCDA compressed air generation and distribution systems for production, laboratories and technik, in Düsseldorf Germany.

Development of the target specification (DQ-URS) together with the customer. Consulting for GMP and FDA appropriate system design and material selection. Planning of the generation and the different conditioning systems as well as the complete supply and piping systems in Microstation Venturis IT 3D. Supplier evaluation and qualification, preparation of the system specification, the BOM and the RFQ documents. Management of the tendering process and support during contracting.  Construction project management – start up, testing and qualification (DQ, IQ, OQ, PQ) together with the customer – documentation check, acceptance test, approval and accounting.

Planning and Project Management Laboratory Installations
Jukos Oil Moscow 2003/4

In co-operation with Mendex and Köttermann Labortechnik responsible for planning and enginereering of the Jukos main laboratory in Moskau Russia, for media supply and disposal systems as well as connection to laboratoy furniture installations and laboratory equipment.

Project Management High Purity Installations Biotechnologie
Boehringer-Ingelheim Pharma Bieberach 2000/2002

For Kinetics GmbH as executive and full responsible head of the on site project organisation for the manufacturing and installation of the 93 km bio-pharm. piping systems in FDA quality, with up to 465 own employees at the installation high phase on site in Biberach Germany.

Project Management Piping Engineering
Beiersdorf AG Hamburg/Sao Paulo 1999/2000

For Kinetics GmbH as subcontractor of M+W responsible for the planning of all the media supply, tank storage and piping systems for the planed new construction of the production facility for toiletries, near Sao Paulo Brasilia.